Correlation of Microbiome and Metabonomics With IgA Nephropathy

March 10, 2025 updated by: XueQing Yu, Guangdong Provincial People's Hospital
IgAN is the most prevalent primary glomerulonephritis in China, is characterized by the deposition of IgA1 (particularly, galactose-deficient IgA1) in the glomerular mesangium. Galactosedeficient IgA1, supposed to be produced by Peyer patches in the mucosa-associated lymphoid tissue (MALT), is triggered by exposure to commensal or pathogenic bacteria, involved in the initial step in the pathogenesis of IgAN. Similar to intestinal flora, a disruption in oral flora is closely associated with the occurrence of many malignant tumors and autoimmune diseases. The relationship between oral and throat microflora and the occurrence of IgAN is unclear at present. The aim of the present study was to develop a preliminary model based on mucosa -specific microbes and clinical indicators to facilitate the early diagnosis of IgAN and obtain insights into its treatment.

Study Overview

Status

Recruiting

Conditions

Detailed Description

IgAN-microbiome is an investigator-initiated，multi-center，Observational study. This study will recruit IgA nephropathy patients who have not been treated with glucocorticoids and immunosuppressants for 6 months and have not taken antibiotics for 1 month and their family members. Feces, urine, blood, oral mucosal swabs, and pharyngeal swabs will be collected and tested for microflora and metabolites in these areas.

Similar samples from IgA nephropathy patients were collected after 2 months and 6 months, respectively, for bacterial community detection and metabolite detection, and the relationship between bacterial community change and metabolite change and disease progression was analyzed.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Hui Peng
      • Guangzhou, Guangdong, China
        • Recruiting
        • The Third Affiliated Hospital of Southern Medical University
        • Contact:
          • Ying Tang
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital Sun Yat-sen University
        • Contact:
          • Qiongqiong Yang
      • Guanzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Principal Investigator:
          • Wei Chen
      • Guanzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
        • Contact:
          • Guangdong Provincial People's Hospital Cai
          • Phone Number: fengtaoc@126.com
          • Email: fengtaoc@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

IgA nephropathy confirmed by renal biopsy and family members living with them

Description

Inclusion Criteria:

  • (1) Pathological changes of IgAN were confirmed by renal biopsy (2) Age ≥16 years (3) IgA deposition caused by secondary factors such as non-purpura glomerulonephritis, liver cirrhosis, SLE, HIV infection and hepatitis B virus associated nephritis (4) No antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month prior to sampling (5) No hormone or immunosuppressant treatment in the six months prior to sampling (6) No significant changes in diet or medication for at least one month (7) No other immune or autoimmune diseases, such as systemic lupus erythematosus (8) Signed informed consent

Exclusion Criteria:

  1. Type I or type II diabetes
  2. Pregnancy and menstrual period
  3. Mental illness and inability to assess follow-up
  4. Medically diagnosed intestinal diseases such as irritable bowel syndrome and inflammatory bowel disease
  5. Viral hepatitis or other infectious diseases
  6. One month before specimen collection, use laxatives including but not limited to polyethylene glycol electrolyte dispersant, enema and other laxatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with all-cause death
Time Frame: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
Death for any reason.
From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
Number of Participants with not meet the entry criteria
Time Frame: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
not meet the entry criteria for any reason
From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Study Chair: Xueqing Yu, Guangdong Provincial People's Hospital
  • Study Director: Zhiming Ye, Guangdong Provincial People's Hospital
  • Study Director: Xinling Liang, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDPH-IgAN-microbiome

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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